The Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Device Description

The NICO-Esprit Interface is a software upgrade to the Esprit Ventilator, which allows the bi-directional communication of the devices to facilitate the transfer of NICO parameters to the Esprit Ventilator as well as the transfer of a patient's breath type information and FiO2 from the Esprit to the NICO Monitor.

AI/ML Overview

The provided text describes a Special 510(k) for a device modification: the Esprit Ventilator with the NICO-Esprit Interface. This application focuses on demonstrating substantial equivalence to already marketed predicate devices, particularly regarding safety and effectiveness, for a software upgrade that allows bi-directional communication between the Esprit Ventilator and the NICO Monitor.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety Testing	Demonstrated compliance with applicable sections of IEC 60601-1-2 and UL 2601.
Software Validation	Performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). Results demonstrated that all design and system requirements for the Esprit ventilator with NICO-Esprit Interface have been met.
Substantial Equivalence	The device has similar performance characteristics, the same intended use, environment of use, and patient populations as the currently marketed predicate devices. The labeling and instructional information is also similar. The addition of the new feature (NICO-Esprit Interface) does not raise new questions of safety or effectiveness.

Study Details:

Sample size used for the test set and the data provenance:
The document does not specify a sample size for a test set or data provenance in the context of clinical performance or accuracy. The testing described is primarily focused on safety and software validation rather than a clinical performance study with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document describes engineering and software validation, not a study involving expert-established ground truth for patient data or diagnoses.
Adjudication method for the test set:
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. The device modification is a software upgrade for ventilator communication, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The provided text describes "Software validation testing," which evaluates the algorithm's performance against its design and system requirements. This could be interpreted as a form of "standalone" evaluation of the software's functionality and correctness, but it's not a standalone clinical performance study in the way it might be for a diagnostic AI algorithm. The device itself (ventilator) is always used with human-in-the-loop operation by medical personnel.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety and software validation, the "ground truth" would be the defined engineering specifications, regulatory standards (like IEC 60601-1-2, UL 2601), and the FDA's software guidance (1998). The software was validated to ensure it met these predetermined requirements, not against clinical outcomes or expert consensus on patient data.
The sample size for the training set:
This information is not applicable/provided. The document describes a software upgrade for an existing medical device, not a machine learning or AI model that typically requires a training set. The validation performed seems to be traditional software testing against defined requirements.
How the ground truth for the training set was established:
This information is not applicable/provided as there is no mention of a training set for an AI model.

Summary

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JUN 1 8 2004

Special 510(k): Device Modification Esprit Ventilator with NICO-Esprit Interface

510(k) SUMMARY 6

CompanyInformation:	Respironics, California Inc.2271 Cosmos CourtCarlsbad, CA. 92009
Contact:	Mary Funk, Regulatory Affairs Project Manager
	Phone Number: (760) 918-7328Fax Number: (760) 918-0169
Date Prepared:	May 11, 2004
Product Name:	Esprit Ventilator with the NICO-Esprit Interface
Common Name:	Ventilator
Classification:	Class IIContinuous Ventilator (per 21 CFR 868.5895)
PredicateDevices:	Respironics Esprit Ventilator	K981072 K001208 K023350, K034040
	Infrasonics Adult Star Ventilator	K964543
	NICO Monitor	K030886

Device Description: 6.1

6.2 Intended Use:

The addition of the NICO-Esprit Interface has not changed the original intended use as described in the labeling. The Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Esprit is not intended for use in the presence of flammable anæsthetics. Esprit is a prescription use device that is intended for sale by or on the order of a physician.

Technological Characteristics: 6.3

The Esprit ventilator does not incorporate any new technological characteristics with the addition of the NICO-Esprit Interface Option.

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Special 510(k): Device Modification Esprit Ventilator with NICO-Esprit Interface

Determination of Substantial Equivalence: 6.4

Ventilator with NICO-Esprit Interface has similar performance The Esprit characteristics, the same intended use and the same environment of use and patient populations as the currently marketed predicate devices. The labeling and instructional information, including warning and caution statements, is similar to that informaticate devices. The addition of this new feature does not raise new questions of safety or effectiveness for the Esprit.

Summary of Performance Testing: 6.5

Safety testing was conducted per the applicable sections of IEC 60601-1-2 and UL 2601. Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with NICO-Esprit Interface have been met.

Conclusion: 6.6

The technological characteristics of the Esprit ventilator with NICO-Esprit Interface and the results of the performance testing do not raise new questions of safety and effectiveness and demonstrate that the device is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2004

Ms. Mary Funk Regulatory Affairs Project Manager Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92009

Re: K041412

Ko41412
Trade/Device Name: Esprit Ventilator with NICO-Esprit Interface Option, Model V1000 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 26, 2004 Received: May 27, 2004

Dear Ms. Funk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette For (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, aters, provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your de vice to such additional controls. Existing major regulations affecting your device can may be subject to back as a sateral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that I'DA's issuance of a substantial equivalence determination does not mean r rease be act nou mail termination that your device complies with other requirements of the Act that + Drimas intatutes and regulations administered by other Federal agencies. You must

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Page 2 – Ms. Mary Funk

comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with all the Act 3 requirements, niems manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Part 017), good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if app 1000, 1050 - This forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050. This product radiation confor provisions (Sections For Sections of Section 510(k) letter will anow you to begin marketing your substantial equivalence of your device to a legally premarket notification. The FDA miding of dassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific advice for your ac not on one on one one the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note Contact the Office of Comphance at (So Frenarket notification" (21CFR Part 807.97). You may obtain "Misbranding by relevelec to premanter notifications in the Act from the Division of Small other general Information on your responsion.com at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k): Device Modification Esprit Ventilator with NICO-Esprit Interface

STATEMENT OF INDICATIONS FOR USE 8

Koy1412-510(k) Number (if known):

Esprit Ventilator with NICO Esprit Interface Device Name:

The Esprit ventilator is a microprocessor controlled, electrically Indications for use: The Eoph vechanical ventilator. It is intended for use by powered, moonanisal personnel in providing continuous or qualificu - modioa. Support for adult and pediatric patients intermittent vontilatory sician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Prescription Use XX (Per 21 CFR 801 subpart D) AND/OR

Over-the-counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hna U. Pinto

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number _

Page 1 of

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).